Northwest Biotherapeutics (NWBO) Offers Additional Data from DCVax-Direct Phase I Trial on Individual Survival Rates

September 29, 2016 9:29 AM EDT
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Northwest Biotherapeutics (Nasdaq: NWBO announced that Dr. Marnix Bosch, Chief Technical Officer of NW Bio, presented additional information relating to the DCVax-Direct Phase I Trial in a poster presentation at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival, being held from September 25th through September 28th in New York City.

Dr. Bosch's New York presentation, as well as his presentation at a cancer vaccines conference in London last week, included information about estimated life expectancies for individual patients (not for types of cancers or medians of groups of patients) based on a system developed and published by Dr. Jennifer Wheler at MD Anderson Cancer Center. The Wheler system was based upon clinical experience with 1,181 patients with diverse cancers at the MD Anderson Phase I Cancer Clinic (where most of the DCVax-Direct Trial was conducted). Wheler validated and enhanced (with additional risk factors) a system for prediction of individual-patient life expectancies previously developed by the Royal Marsden Hospital in the UK and well established in the field.

A fundamental purpose of early stage exploratory trials, such as the DCVax-Direct Phase I trial, is to evaluate both product characteristics and patient characteristics – and especially to identify which patients show the best responses to the experimental product. Such evaluations enable later stage trials to be designed with more precision, to focus on the patients who are the best fit for the experimental product and to potentially best demonstrate the performance of the experimental product.

Exploratory trials typically involve diverse patient populations, as did the DCVax-Direct Phase I Trial. In evaluating the results of such trials, it is especially helpful to be able to identify life expectancies for individual patients, and compare those expectations to the actual results obtained in those individual patients. Patient-specific assessments are still estimates, but are more precise than general assessments relating to types of cancer or medians of groups of patients. Patient-specific assessments also can be more relevant, taking account of diversity among the patients.

The DCVax-Direct Phase I Trial included more than a dozen different types of cancers, as well as sub-types (e.g., several different types of sarcoma), patients with varying numbers of inoperable and locally advanced or metastatic tumors, and varying numbers and types of prior treatment regimens that had all failed. This diversity enabled demonstration, in a wide range of settings, of the safety and feasibility of DCVax-Direct (including feasibility of the novel intra-tumoral injections) as well as an initial signal or indication of potential results.

As explained in Dr. Bosch's poster presentation, under the Wheler methodology individual life expectancy is determined through measurements of 5 key risk factors: serum albumin, serum LDH, number of metastases, GI tumor, and ECOG (Eastern Cooperative Oncology Group) performance status. The expected survival is 24.0, 15.2, 8.4, 6.2 or 4.1 months for patients with 0, 1, 2, 3 or 4-5 of the above risk factors, respectively.

Dr. Bosch's New York and London presentations applied the Wheler system to determine estimated individual-patient life expectancies, and compare those to the actual clinical results in each patient in the top 30% of patients in the DCVax-Direct Phase I Trial. Dr. Bosch's poster will be available on the Company's website starting today.

The top 20% of the patients in the DCVax-Direct Phase I Trial have each exceeded 2 years of survival so far, and are still alive. The longest survivor to date has reached nearly 3 years.

The top 30% of the patients in the DCVax-Direct Phase I Trial (including pancreatic, melanoma, lung, ovarian, sarcoma and other cancers) have average actual individual survival to date of 26.7 months, compared with average expected individual survival of 12.3 months.

The Wheler system for assessing individual patient life expectancies can be found at Wheler, et al.; Survival of 1,181 Patients in a Phase I Clinic: The MD Anderson Clinical Center for Targeted Therapy Experience. Clin. Cancer Res. 2012 May 15; 18(10): 2922–2929.

Dr. Bosch's presentation also included assessments of dendritic cell quality and their relationship with patient outcomes, such as stabilization of disease and overall survival. The encouraging survival results correlate with underlying mechanisms of action and cellular and immune profiles, including phenotype analyses, and relative production of a wide range of cytokines by the dendritic cells. Additional positive observations include T-cell infiltration, and PD-L1 expression, with 64% of the patients evaluable for PD-L1 checkpoint expression (14 of 22) showing either de novo or significantly increased expression of PD-L1 following DCVax-Direct treatment, indicating potential for combination of DCVax-Direct and checkpoint inhibitors. Such information will also be helpful in shaping later stage trials.

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